500 mg/50 mg effervescent tablet
acetylsalicylic acid/caffeine
What Tiplo is and what it is used for
Tiplo contains a combination of acetylsalicylic acid and caffeine.
Tiplo has an analgesic, antipyretic, and anti- inflammatory effect.
Acetylsalicylic acid relieves pain by counteracting the formation of special substances, prostaglandins. The antipyretic effect is due to acetylsalicylic acid increasing the body’s heat output.
Caffeine enhances the pain-relieving effect of acetylsalicylic acid. Caffeine also has an analgesic effect through its constricting effect on dilated blood vessels in the brain, e.g. in the case of migraine.
Caffeine also has an invigorating effect.
With water, Tiplo gives a clear solution that is gentler on the stomach than regular solid tablets with acetylsalicylic acid. Tiplo starts working within 30 minutes. The effect is greatest after 1-2 hours.
This medicine is used for temporary mild to moderate pain conditions, e.g. headaches, migraine headaches, toothaches, muscle, and joint pains, menstrual pains, and in cases of fever in cold diseases.
You must speak to a doctor if you do not feel better or if you feel worse after 3 days for fever and migraine and 5 days for pain.
The combination of acetylsalicylic acid and caffeine found in Tiplo may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tiplo
Do not use Tiplo
- if you are allergic to acetylsalicylic acid, caffeine, or any other ingredient in this medicine (listed in section 6).
- if you have had any hypersensitivity reaction such as asthma, breathing difficulties, hay fever, or hives when taking aspirin or certain other anti-inflammatory medicines
- if you have a stomach ulcer
- if you have hemophilia or a reduced number of blood platelets ( thrombocytopenia )
- if you have cirrhosis of the liver ( liver cirrhosis )
- if you have severe heart failure
- if you have severe kidney disease
- if you are pregnant in the last three months of pregnancy (see “Pregnancy, breastfeeding and fertility”).
Warnings and precautions
Higher doses than those recommended may entail serious risks. Do not use different types of pain relievers at the same time without a doctor’s prescription.
Talk to your doctor, pharmacist, or nurse before using Tiplo:
- if you have asthma
- if you have mild to moderate heart failure
- if you have kidney disease or liver disease, especially during concomitant treatment with diuretics
- if you take medicines that thin the blood to prevent blood clots ( anticoagulants )
- if you have had a stomach ulcer
- if you are hypersensitive to acetylsalicylic acid, ibuprofen, or other anti-inflammatory agents
- if you are trying to get pregnant.
Due to its caffeine content, Tiplo can make it difficult to fall asleep if you take it close to bedtime.
Long-term use of painkillers for headaches can worsen the headache. If you have or think you have such a headache, you should seek medical advice and stop treatment.
Children and young people
Tiplo should not be used by children under 14 years of age.
Medicines containing acetylsalicylic acid should not be given to people under the age of 18 with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.
Other medicines and Tiplo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Treatment with Tiplo can affect or be affected by certain medicinal substances against:
- Anticoagulants (drugs against blood clots, e.g. warfarin )
- Cyclosporine and tacrolimus (anti-rejection medicines for transplanted organs)
- Diuretics and medicines for high blood pressure
- Corticosteroids (medicines against inflammation, e.g. cortisone or prednisolone ) and other NSAIDs (medicines against pain and inflammation, e.g. ibuprofen )
- Probenecid (for gout )
- Methotrexate (against cancer and rheumatism)
- Acetazolamide (medication for glaucoma, also called glaucoma )
- Digoxin and adenosine (medicines for heart rhythm disorders)
- Fluvoxamine (medicine against depression called SSRIs, selective serotonin reuptake inhibitors)
- Clozapine (anti-schizophrenia)
- Lithium (for manic depression)
- Phenytoin , valproic acid , carbamazepine (for epilepsy )
- Sulfonureides (drugs for type II diabetes )
- Nicotinic acid (against high blood fats)
- Ciprofloxacin, norfloxacin ( antibiotics against infection )
- Phenylpropanolamine (anti- allergy medicine )
Tiplo with food and drink
Tiplo in combination with alcohol may increase the risk of bleeding in the gastrointestinal tract.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Pregnant women should not use Tiplo during the last three months of pregnancy. Ingestion of Tiplo should be avoided by women planning a pregnancy or who are pregnant. Treatment during any part of the pregnancy must only take place after a doctor’s prescription.
Breast-feeding
Acetylsalicylic acid and caffeine pass into breast milk but probably do not affect the breastfed baby. However, talk to your doctor if you use Tiplo more than occasionally during breastfeeding.
Fertility
Tiplo, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to get pregnant and is therefore not recommended for women who are trying to get pregnant. The effect is temporary, i.e. it stops when you stop using these types of drugs.
Driving ability and use of machinery
In some people, Tiplo can impair the ability to react, e.g. due to side effects such as dizziness and fatigue. This should be considered at times when increased attention is required, e.g. when driving.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tiplo contains sodium and sodium benzoate
This medicine contains 345 mg of sodium (the main ingredient in common salt/table salt) per effervescent tablet. This corresponds to 17.3% of the maximum recommended daily intake of sodium for adults. Consult a doctor or pharmacist about your need for Tiplo or more effervescent tablets daily for a longer period, especially if you have been prescribed a low-salt (low-sodium) diet.
This medicine contains 0.15 mg of sodium benzoate per effervescent tablet.
How to use Tiplo
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
Tiplo effervescent tablets are intended for temporary discomfort.
The recommended dose for adults and adolescents over 14 years of age:
1-2 effervescent tablets 1-3 times per day or according to the doctor’s prescription, maximum of 6 tablets per day.
More than 2 effervescent tablets at a time do not provide a better pain-relieving effect. Contact the doctor if the symptoms worsen or do not improve within 3 days for fever and migraine and within 5 days for pain.
Use for children
Tiplo should not be given to children under 14 years of age.
Warning: Should not be given to people under 18 years of age with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.
Dissolve the fizzy tablets in half a glass of water.
As caffeine is a stimulant, it may not be appropriate to take this medicine at night.
If you have used too much Tiplo
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose may include headache, dizziness, convulsions, vomiting, ringing in the ears, palpitations ( tachycardia ), abdominal pain, irritation, restlessness, and shortness of breath.
If you forget to take Tiplo
Do not take a double dose to make up for a missed tablet.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects ( may affect up to 1 in 10 users):
- stomach upset, such as acid reflux, heartburn, and nausea
- increased risk of bleeding
- palpitations, tremors, restlessness, insomnia.
Uncommon side effects ( may affect up to 1 in 100 users):
- fatigue, sweating, dizziness, and tinnitus
- hypersensitivity reactions such as hives, hay fever, or shortness of breath
- stomach ulcers and stomach bleeding.
Rare side effects ( may affect up to 1 in 1,000 users):
- decrease in the number of blood platelets ( thrombocytopenia )
- dissolution of the red blood cells ( hemolysis ) in those who have a hereditary deficiency of the metabolic enzyme glucose -6-phosphate dehydrogenase
- severe bleeding in the gastrointestinal tract
- severe skin reactions
- liver damage
- kidney damage.
Smaller blood losses can in some cases lead to anemia.
Dizziness and ringing in the ears can be symptoms of overdose.
Additional side effects are in children
Acetylsalicylic acid may increase the risk of Reye’s syndrome in children and adolescents in connection with diseases caused by viruses, especially chickenpox and influenza. Reye’s syndrome is very rare. The symptoms consist of signs of swelling in the brain and liver damage, sometimes with low blood sugar.
How to store Tiplo
Store at a maximum of 30 °C.
Store in the original packaging. Moisture sensitive.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are acetylsalicylic acid 500 mg, and caffeine 50 mg per effervescent tablet.
- Other ingredients are sodium bicarbonate; citric acid, anhydrous; sodium benzoate, and docusate sodium.
Appearance and package sizes of the medicine
Appearance
Tiplo effervescent tablets are 20 mm in diameter, round, white and flat tablets.
Package sizes
The effervescent tablets are in an aluminum tube with a plastic lid. In the lid, there is a desiccant consisting of silica gel.
20 pcs in a tube and outer carton.
60 pcs (3 x 20 pcs) in a tube and outer carton.
Not all pack sizes may be marketed.
Orifarm Generics A/S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
BOX 56048
10217 Stockholm
info@orifarm.com